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Plain-language guide to NCT00492934: not phased randomized trial of HMG (Human Menopausal Gonadotropin), 300 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00492934
- Phase
- not phased
- Status
- status unknown
- Start
- 2004-01
- Completion (planned or actual)
- 2013-10
- Participants
- 300 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Infertility
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around HMG (Human Menopausal Gonadotropin).
It had two arms (groups): 1 (active comparator) and 2 (no intervention).
No daily injections with hormones.
The registry classes the interventions as drug.
Who Took Part
The registry lists 300 planned participants were the target.
It was open to women only aged from 21 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Signed informed consent. Women with a regular cycle (between 21 and 35 days). Embryo and endometrium are synchronized.
The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: embryo storage time not longer than 5 years.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the HMG (Human Menopausal Gonadotropin) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when HMG (Human Menopausal Gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2004-01 with completion listed for 2013-10.
It ran at 1 site in Belgium.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: implantation rate per embryo (time frame: 15 days after the embryo transfer).
It also tracked 1 secondary outcome, for example thickness of the endometrium.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) in 300 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.
Our Notes on the Compound
HMG (Human Menopausal Gonadotropin): Menotropins: a glycoprotein preparation that supplies follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.